Urological implant having extraction handle and/or arched members

ABSTRACT

Embodiments of a Urological implant include an implant with an elongated body having a longitudinal axis. Optionally longitudinal ribs symmetrically oppose each other and are connected to elongated body. The longitudinal ribs are optionally elastically shiftable between a collapsed state and an expanded state relative to the spinal longitudinal axis, in order to retract or/and support periurethral tissue. Optionally the system includes an implant extraction handle. The extraction handle is optionally positioned proximally to the elongated body and connected to the longitudinal rib and subject to a pulling force to facilitate and/or force approximation of the longitudinal supports to the longitudinal axis. In some embodiments, an implant body includes longitudinally spaced arched members, interconnected via arch ends sequentially along a length of a first and second longitudinal rib. Optionally the arched members are elastically bendable to facilitate elastic contractibility of the implant body under a transverse compressive force.

RELATED APPLICATIONS

This application is a Divisional application of U.S. patent applicationSer. No. 16/770,602 filed Jun. 7, 2020, which is a national stage entryof International Application PCT/IL2018/051321 filed 3 Dec. 2018 andclaims priority from U.S. Provisional Patent Application No. 62/595,147filed 6 Dec. 2017 and from U.S. Provisional Patent Application No.62/644,627 filed Mar. 19, 2918,

This application claims priority of U.S. patent application Ser. No.16/770,602 filed Jun. 7, 2020, International ApplicationPCT/IL2018/051321 filed 3 Dec. 2018, of U.S. Provisional PatentApplication No. 62/595,147 filed 6 Dec. 2017 and of U.S. ProvisionalPatent Application No. 62/644,627 filed Mar. 19, 2918.

The contents of the above applications are all incorporated by referenceas if fully set forth herein in their entirety.

FIELD OF THE INVENTION

The present invention, in some embodiments thereof, relates to the fieldof urological medical devices and applications thereof, and moreparticularly, but not exclusively, to a urological (prostatic) implant,system, and method for retracting or/and supporting a prostatic urethraand/or periurethral tissue enclosing a prostatic urethra along a lengthof prostate lobes.

BACKGROUND OF THE INVENTION

Benign prostate hyperplasia (BPH), also known as benign prostatichypertrophy, is a urological disease in which the prostate enlarges andconstricts the urethra. BPH affects a majority of the male populationover 50 years of age, and is thus of great medical and commercialimportance.

Surgical treatment of hypertrophy of the prostate has been a routineprocedure for many years. One method of such surgical treatment is openprostatectomy wherein the gland is totally or partially removed. Anothermethod of surgical treatment is transurethral resection of the prostate(TURP). Surgical treatment is an invasive procedure that may bedebilitating, painful and traumatic to the patient. Such surgicaltreatment may result in various complications including impotence,incontinence, bleeding, infection, and other undesirable problems.

Another procedure to treat prostatic hypertrophy is to place a catheterat the external opening of the urethra and into the obstructed portionsof the urethra, allowing urine to pass from the bladder by way of thecatheter lumen. These urinary catheters typically employ a positioningor retention balloon at the distal tip which inflates at the bladderneck and prevents the expulsion of the catheter from the body.

Ablation techniques based on using heat, such as produced by microwaveor laser energy, may be provided in combination with such catheters fortreating the enlarged portion of the prostate. However, such a proceduremay result in pain and discomfort to the patient.

In spite of extensive teachings and practices in the field of urology,there is an on-going need for developing and practicing improved and newurological medical devices and applications thereof, for treating benignprostate hyperplasia (BPH).

SUMMARY OF THE INVENTION

The present invention, in some embodiments thereof, relates to aurological (prostatic) implant, system, and method for retracting or/andsupporting periurethral tissue enclosing a prostatic urethra along alength of prostate lobes.

According to an aspect of some embodiments of the invention, there isprovided an implant for retracting or/and supporting a prostatic urethrawall, the implant having an elongated implant body defining alongitudinal channel having a longitudinal axis, extending between acranial end and a caudal end of the implant body; a pair of cranialprojections configured to rest on a ledge of a bladder neck therebypreventing cranial drift of the implant into a bladder; a median planeincluding the longitudinal axis and perpendicular to a line connectingthe cranial projections, the median plane having an anterior-posterioraxis perpendicular to the longitudinal axis and wherein the line betweenthe pair of cranial projections crosses the channel laterally on aposterior portion thereof.

According to some embodiments of the invention, a lateral width of aposterior portion of the channel is greater than a lateral width of ananterior portion of the channel.

According to some embodiments of the invention, the median plane dividesthe implant body into two symmetrical lateral halves.

According to some embodiments of the invention, the implant furtherincludes a pair of posterolateral retractors; at least one cranialinterconnecting member connecting a cranial portion of each of the pairof posterolateral retractors to a cranial anterior apex located on themedian plane, wherein in an unstressed configuration the at least onecranial interconnecting member extends laterally and posteriorly fromthe cranial anterior apex to each of the posterolateral retractors; atleast one caudal interconnecting member connecting a caudal portion ofeach of the pair of posterolateral retractors to a caudal anterior apexlocated on the median plane, wherein in an unstressed configuration theat least one caudal interconnecting member extends laterally andposteriorly from the caudal anterior apex to each of the posterolateralretractors; and wherein one of the pair of cranial projectionprojections projects in a cranial direction from each of theposterolateral retractors beyond the cranial interconnecting member.

According to some embodiments of the invention, in the unstressedconfiguration, a lateral width of the implant body between the pair ofcranial projections is greater than a lateral width of the implant bodybetween the caudal portions of the pair of posterolateral retractors.

According to some embodiments of the invention, the implant where aratio of the width of the between the caudal portions of the pair ofposterolateral retractors to the lateral width between the pair ofcranial projections ranges between 9/10 to 6/10.

According to some embodiments of the invention, a height in an anteriordirection of the cranial apex from the cranial portion of theposterolateral retractors is greater than a height in the anteriordirection of the caudal apex from the caudal portion of theposterolateral retractors.

According to some embodiments of the invention, each of the at least onecranial connecting member and the at least one caudal connecting memberis elastically bendable so as to facilitate elastic contractibility ofthe implant body when the implant body is subjected to a transversecompressive force crossing the median plane.

According to some embodiments of the invention, a ratio of a length ofthe implant in a longitudinal direction and an average anterior heightof the cranial apex and the caudal apex from the pair of posterolateralretractors ranges between 12/10 to 16/10.

According to some embodiments of the invention, the implant furtherincludes: wherein the at least one caudal connecting member isconfigured to shift elastically, under a pulling force away from the atleast one cranial connecting member to facilitate approximation of thepair of posterolateral retractors relative to the longitudinal axis.

According to some embodiments of the invention, the implant body has atotal height in an anterior posterior direction within a range of 10 mmto 40 mm and a width in a lateral direction within a range of 8 mm to 30mm, when in an expanded configuration.

According to some embodiments of the invention, a posterior side of theimplant body is open.

According to an aspect of some embodiments of the invention, there isprovided a set of implants for a prostatic urethra including: a largeimplant having an elongated implant body having a longitudinal axis, thelongitudinal axis extends between a cranial end and a caudal end of theimplant body along a median plane dividing the implant body into twosymmetrical halves the median plane having an anterior-posterior axisperpendicular to the longitudinal axis is perpendicular to a transverseplane and, the transverse plane having lateral axis perpendicular to thean anterior-posterior axis and perpendicular to the longitudinal axis; apair of posterolateral retractors; a small implant proportionallysimilar within 10% to the large implant.

According to some embodiments of the invention, in an unstressedconfiguration, a lateral width of a cranial end portion of the implantbody is greater than a lateral width of a caudal end portion of theimplant body.

According to some embodiments of the invention, the set where a ratio ofthe width of a caudal end portion and the lateral width of a cranial endportions ranges between 9/10 to 6/10.

According to some embodiments of the invention, a height in an anteriordirection of a cranial end portion of the implant body is greater than aheight in the anterior direction of a caudal end portion of the implantbody.

According to some embodiments of the invention, a ratio the height inthe anterior direction of the cranial portion to the height in theanterior direction of the caudal end portion ranges between 11/10 to14/10.

According to some embodiments of the invention, each implant body iselastically bendable so as to facilitate elastic contractibility of theimplant body when the implant body is subjected to a transversecompressive force crossing the median plane.

According to some embodiments of the invention, the large implant has atotal height in an anterior posterior direction within a range of 30 mmto 40 mm and a width in a lateral direction within a range of 22 mm to30 mm, when in an expanded configuration and the small implant has atotal height in the anterior posterior direction within a range of 10 mmto 13 mm and a width in the lateral direction within a range of 8 mm to11 mm, when in an expanded configuration.

According to some embodiments of the invention, a posterior side of theimplant body is open.

According to an aspect of some embodiments of the invention, there isprovided a urological implant, including: an connecting member; a firstlongitudinal rib and a second longitudinal rib symmetrically opposingeach other and elastically shiftable away from each other between acollapsed state and an expanded state, relative to a longitudinal axisof the implant; the expanded state for retracting or/and supportingperiurethral tissue enclosing a prostatic urethra; and an implantextraction handle connected at one side thereof to the firstlongitudinal rib and at second side thereof to the second longitudinalrib, wherein the extraction handle is configured to shift elastically,under a pulling force away from the connecting member to facilitateand/or force approximation of the first and second longitudinal ribsrelative to the longitudinal axis.

According to some embodiments of the invention, the connecting memberincludes at least one arched member connecting at one end thereof to thefirst longitudinal rib and on a send end thereof to the secondlongitudinal rib.

According to some embodiments of the invention, the arched member isinclined distally in the expanded state.

According to some embodiments of the invention, implant is configured tocollapse to an insertion configuration fitting into a urinary catheterwherein the handle is collapsed distally.

According to some embodiments of the invention, implant is configured tocollapse to an extraction configuration fitting into a urinary catheterwherein the handle is collapsed proximally.

According to some embodiments of the invention, a distal end of theconnecting member is configured to remain proximal to a distal end ofthe rib in the expanded state.

According to some embodiments of the invention, a distal end of theconnecting member is configured to remain proximal to a distal end ofthe rib in the collapsed state.

According to an aspect of some embodiments of the invention, there isprovided a urological implant having extraction handle. Optionally, theimplant has an elongated implant body having a longitudinal axis and twoor more longitudinal ribs elastically shiftable away from each otherbetween a collapsed state and an expanded state, relative to thelongitudinal axis. Optionally, the device may be biased to the expandedstate. For example, the device may be configured for supportingperiurethral tissue enclosing a prostatic urethra in the expanded state.Optionally, in the collapsed state the device may be inserted and/orextracted from the urethra (for example using a sheath and/or a catheterfor example the sheath may have an internal diameter between 2 to 4 mmand/or between 4 to 6 mm and/or between 6 to 10 mm), for example thedevice may collapse to a width of between 2 to 4 mm and/or 4 to 6 mmand/or between 6 to 8 mm and/or between 8 to 10 mm. In some embodiments,pulling implant extraction handle proximally urges the device toward thecollapsed state.

In some embodiments, the extraction handle is attached to the implantbody, for example to a proximal portion thereof. Optionally, one side ofthe longitudinal rib is connected at to a first longitudinal rib and atsecond side thereof to a second longitudinal rib. Optionally, theextraction handle is configured to shift elastically, under a pullingforce away from the implant body to facilitate and/or forceapproximation of the first and second longitudinal ribs relative to thelongitudinal axis.

In some embodiments, the longitudinal ribs are interconnected by aconnecting member. For example, the connecting member may include alongitudinal spine and/or one or more arched members. Optionally thefirst and second longitudinal ribs symmetrically oppose each other.Optionally, the device is in the expanded state when the connectingmember is in a relaxed state and/or the device body forces thelongitudinal ribs outward as the device collapses towards the collapsedstate.

Some embodiments are further characterized in that the implantextraction handle is shaped to correspond to an outline of theurological implant at a proximal end thereof in the expanded relaxedstate.

Some embodiments are further characterized in that the extraction handleincludes an apex.

Some embodiments are further characterized in that the apex is centeredbetween the first and second longitudinal ribs.

Some embodiments are further characterized in that in the relaxed statethe apex is adjacent to a proximal end of the implant body and thepulling causes the apex to move in a proximal direction away from theimplant body proximal end.

Some embodiments are further characterized in that the implantextraction handle is symmetrically connected to the first and secondlongitudinal ribs.

According to an aspect of some embodiments of the present invention,there is provided a urological implant, comprising:

-   -   an elongated implant body having a longitudinal axis;    -   a first longitudinal rib and a second longitudinal rib        symmetrically opposing each other and connected to the implant        body, and elastically shiftable away from each other between a        collapsed state and a relaxed state, relative to the        longitudinal axis, for retracting or/and supporting periurethral        tissue enclosing a prostatic urethra; and    -   an implant extraction handle provided proximally distant to the        implant body and symmetrically connected at one side thereof to        the first longitudinal rib and at second side thereof to the        second longitudinal rib.

In some embodiments, the implant extraction handle is shaped tocorrespond an outline of the urological implant formed by the first andsecond longitudinal ribs with an extraction handle apex thereof providedadjacent a proximal end of the implant body,

In some embodiments, the implant extraction handle is configured toshift elastically, when under a pulling force originating therefrom,such that the extraction handle apex points in a proximal directiontowards and/or along the longitudinal axis and away from the implantbody proximal end, so as to facilitate and/or force approximation of thefirst and second longitudinal ribs relative to the longitudinal axis.

In some embodiments, the implant body includes a spine member.

In some embodiments, the implant extraction handle configured torecollapse the first and second longitudinal ribs into the collapsedstate, when the urological implant is pulled proximally from the implantextraction handle against an edge of a retraction sheath enclosing alumen sized to accommodate the urological implant therein when in thecollapsed state.

In some embodiments, each the first and second longitudinal ribsincludes a proximally projecting lateral corner and a distallyprojecting lateral corner, relative to the longitudinal axis, and theimplant extraction handle is connected to the first and secondlongitudinal ribs at the proximally projecting lateral corners thereofso as to facilitate forcing of the proximally projecting lateral cornersto approximate each other when the urological implant is pulledproximally from the implant extraction handle against the sheath edge.

In some embodiments, each the first and second longitudinal ribs iscurved and includes a proximal rib end joined to a proximal end of thespine member, a distal rib end joined to a distal end of the spinemember, and an elongated rib edge portion provided between the proximaland distal corresponding rib ends that is sized and shaped forpositioning in a corresponding posterolateral interlobar groove, whenthe spine member is positioned in and along an anterior interlobargroove in the prostatic urethra.

According to an aspect of some embodiments of the present invention,there is provided a method for extracting the urological implant,comprising:

-   -   positioning the edge of the extraction sheath in the prostatic        urethra;    -   applying a fastener to emerge from the extraction sheath        distally into the prostatic urethra and to fasten onto a        mid-portion of the implant extraction handle; and    -   pulling the urological implant proximally from the implant        extraction handle against the sheath edge, thereby recollapsing        the urological implant until reaching the collapsed state and        further withdrawing the urological implant into the extraction        sheath lumen.

In some embodiments, pulling the urological implant deforms the implantextraction handle such that deformation stresses developed thereinsideforce the first and second longitudinal ribs to approximate one to otheruntil reaching the collapsed state.

In an aspect of some embodiments of the present invention, there isprovided a urological implant for retracting or/and supporting aprostatic urethra wall. The implant comprising an elongated implant bodyhaving a longitudinal axis, the longitudinal axis is perpendicular to atransverse plane and extending between a cranial end and a caudal end ofthe implant body along a median plane. Optionally the longitudinal axisdivides the implant body into two symmetrical halves.

In some embodiments, the implant body includes longitudinally spacedarched members, each of the arched members includes an unsupported archapex located between a first arch end and a second arch end, formingtogether an arched member plane being perpendicular to the median plane.

In some embodiments, the arched members are interconnected via arch endsthereof. For example, the first arch ends of the arched members may beconnected sequentially along a length of a first longitudinal ribportion, and/or the second arch ends of the arched members may beconnected sequentially along a length of a second longitudinal ribportion. Optionally, each of the first and second longitudinal ribportions extends through the transverse plane;

In some embodiments, each one of the arched members is elasticallybendable so as to facilitate elastic contractibility of the implant bodywhen the implant body is subjected to a transverse compressive forcecrossing the median plane.

In some embodiments, the implant body is sized and configured to retractor/and support an anterior portion of the prostatic urethra wall, andallowing collapse of an unsupported posterior portion of the prostaticurethra wall opposing the anterior portion.

In some embodiments, the implant body further includes a first lateralspacer emerging from the first longitudinal rib and a second lateralspacer emerging from the second longitudinal rib, being independentlycontractible when subjected to a sagittal compressive force parallel tothe median plane.

In an aspect of some embodiments of the present invention, there isprovided a method for supporting or/and extracting a wall of a partiallyconstricted prostatic urethra, the method comprising:

providing the urological implant;

positioning the implant in the partially constricted prostatic urethrawith the implant body contracted into a chosen contracted size and shapeconfigured for atraumatic insertion in the partially constrictedprostatic urethra, wherein each the arch apex is located adjacentmidline of an anterior portion of the prostatic urethra wall;

releasing the implant body thereby allowing the arched members toautonomously shift the first and second longitudinal rib portions awayfrom each other relative to the median plane, to contact the wall of thepartially constricted prostatic urethra and to retract the prostaticurethra by pressing against the prostatic urethra wall.

All technical or/and scientific words, terms, or/and phrases, usedherein have the same or similar meaning as commonly understood by one ofordinary skill in the art to which the invention pertains, unlessotherwise specifically defined or stated herein. Methods, materials, andexamples described herein are illustrative only and are not intended tobe necessarily limiting. Although methods or/and materials equivalent orsimilar to those described herein can be used in practicing or/andtesting embodiments of the invention, exemplary methods or/and materialsare described below. In case of conflict, the patent specification,including definitions, will control.

Implementation of some embodiments of the invention can involveperforming or completing selected tasks manually, automatically, or acombination thereof. Moreover, according to actual instrumentation andequipment of some embodiments of the invention, several selected taskscould be implemented by hardware, by software, by firmware, or acombination thereof, using a computerized operating system.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the present invention are herein described, by wayof example only, with reference to the accompanying drawings. Withspecific reference now to the drawings in detail, it is stressed thatthe particulars shown are by way of example and for purposes ofillustrative description of some embodiments of the present invention.In this regard, the description taken together with the accompanyingdrawings make apparent to those skilled in the art how some embodimentsof the present invention may be practiced.

In the drawings:

FIGS. 1A-1D schematically illustrate cross sectional views of a maleurethra shown in a constricted state (FIG. 1C) and in a patent state(FIG. 1D), in accordance with some embodiments of the invention;

FIGS. 1E-1F show views of an exemplary urological implant comprising animplant extraction handle, in accordance with some embodiments of theinvention;

FIG. 2 shows the urological implant of FIG. 1 deployed in a prostaticurethra model, in accordance with some embodiments of the invention; and

FIGS. 3A-3F show various exemplary scenarios representing stages in anexemplary method of extracting the urological implant of FIGS. 1 , inaccordance with some embodiments of the invention.

FIGS. 4A-4D schematically illustrate views of an exemplary urologicalimplant having two spaced arches, in accordance with some embodiments ofthe invention;

FIGS. 5A-5C schematically illustrate views of an exemplary urologicalimplant having two lateral spacers, in accordance with some embodimentsof the invention;

FIGS. 6A-6C illustrate views of an exemplary urological implant havingthree spaced arches, two lateral spacers and an extraction handle, inaccordance with some embodiments of the invention;

FIG. 7 is a flow chart illustration of method for extracting aurological implant in accordance with an embodiment of the currentinvention;

FIG. 8 is a block diagram of a urological implant in accordance with anembodiment of the current invention;

FIG. 9 is a perspective view of a three arched urological implant in anexpanded state accordance with an embodiment of the current invention;

FIG. 10 is a bird's eye view of a three arched urological implant in anexpanded state in accordance with an embodiment of the currentinvention;

FIG. 11 is a side view of a three arched urological implant in acollapsed state for insertion into a urethra in accordance with anembodiment of the current invention;

FIG. 12 is a bird's eye view of a three arched urological implant in acollapsed state for insertion into a urethra in accordance with anembodiment of the current invention;

FIG. 13 is a side view of a four arched urological implant 1301 in acollapsed state for extraction from a urethra in accordance with anembodiment of the current invention;

FIG. 14 illustrates 4 sizes of implants a large implant 1400 a, amedium-large implant 1400 b, a medium implant 1400 c and a small implant1400 d in accordance with embodiments of the current invention;

FIG. 15 illustrates a distal (e.g. cranial) end view of a flat implantblank before folding in accordance with an embodiment of the currentinvention;

FIG. 16 is an anterior view of a flat implant blank after cutting and/orbefore folding in accordance with an embodiment of the currentinvention;

FIG. 17 illustrates folding of an implant in accordance with anembodiment of the current invention;

FIG. 18A is a lateral orthogonal view of an implant in accordance withIn some embodiments of the current invention;

FIG. 18B is an axial view of an implant in accordance with an embodimentof the current invention;

FIG. 19 is a cranial posterior view of a tubular implant in accordancewith an embodiment of the current invention;

FIG. 20 is a cranial posterior view of a tapered tubular implant inaccordance with an embodiment of the current invention;

FIG. 21 is a lateral cranial view of a tapered tubular implant inaccordance with an embodiment of the current invention;

FIG. 22 is a posterior cranial view of a tapered tubular implant inaccordance with an embodiment of the current invention; and

FIG. 23 is a posterior orthogonal view of a tapered tubular implant inaccordance with an embodiment of the current invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to the fieldof urological medical devices and applications thereof, and moreparticularly, but not exclusively, to a urological (prostatic) implant,system, and method for retracting or/and supporting a wall of aprostatic urethra and/or periurethral tissue enclosing a prostaticurethra along a length of prostate lobes.

FIGS. 1A-1D schematically illustrate cross sectional views of a maleurethra. FIG. 1B is a magnification of the body portion containing theprostatic urethra. The urethra connects the urinary bladder to theurinary meatus for the removal of urine and semen from the body.Furthermore, the prostatic urethra merges about mid length thereof withan ejaculatory duct for carrying semen therein from the seminal vesicle.The prostatic urethra begins at the bladder neck and runs through theprostate approximately 3 cm in length. It begins almost vertically (in acaudal direction) from the bladder then curved anteriorly. In viewthereof, inventor believes a urological implant having a curved bodymimicking prostatic urethra curvature is advantageous for both immediateimplantation phase, and for long term presence in the prostatic urethra,so as to physically effect and maintain a healthy and patent prostaticurethra.

FIGS. 1C-1D illustrate a cross section of the prostatic urethra alongline ‘1C:1C’. FIG. 1C shows the prostatic urethra in a constrictedstate, whereas a normal state would be more similar to a trefoil(three-lobed) shape. FIG. 1D, on the other hand, illustrates a patent,partially opened, state with an anterior lobe fully opened, yet the twoposterior lobes substantially closed. The patent state shown in FIG. 1Dis considered by the inventor of the present invention as havingadvantages even with respect to the natural fully opened state, sincethat it suppresses retrograde (cranial) flow towards the urine bladderthe of semen arriving at the posterior portion of the prostatic urethravia the ejaculatory duct.

FIGS. 1E-1F show views of an exemplary urological implant 100 and FIG. 2shows the urological implant 100 deployed in a prostatic urethra model200. Urological implant 100 includes:

-   -   (1) an elongated body including a spine member 101 having a        longitudinal axis X;    -   (2) a first longitudinal rib 102 and a second longitudinal rib        103 symmetrically opposing each other and connected to elongated        body (spine member) 101. First and second longitudinal ribs are        elastically shiftable away from each other between a collapsed        state (shown in FIG. 3E, for example) and a relaxed state (shown        in FIGS. 1E and 1F, for example), relative to spinal        longitudinal axis X, in order to retract or/and support        periurethral tissue enclosing the prostatic urethra 200; and    -   (3) an implant extraction handle 104 provided proximally distant        to spine member 101 (see gap 105) and symmetrically connected at        one side 106 thereof to first longitudinal rib 102 and at second        side 107 thereof to second longitudinal rib 103.

Implant extraction handle 104 is shaped to correspond an outline of theurological implant 100 formed by the first and second longitudinal ribs102 and 103 with an extraction handle apex 120 thereof provided adjacenta proximal end 121 of the implant body 101.

Implant extraction handle 104 is configured to shift elastically, whenunder a pulling force originating therefrom, such that the extractionhandle apex 120 points in a proximal direction towards and/or along thelongitudinal axis X and away from the implant body proximal end 121, soas to facilitate and/or force approximation of the first and secondlongitudinal ribs 102 and 103 relative to longitudinal axis X.

Implant extraction handle 104 is configured to recollapse first andsecond longitudinal ribs 102 and 103 into the collapsed state, when theurological implant 100 is pulled proximally from implant extractionhandle 104 against an edge of a retraction sheath enclosing a lumensized to accommodate the urological implant therein when in collapsedstate (as will be further detailed below in the description relating toFIG. 3 ).

Each of first and second longitudinal ribs 102 and 103 includes aproximally projecting lateral corner 108 and a distally projectinglateral corner 109, relative to longitudinal axis X. Implant extractionhandle 104 is connected to first and second longitudinal ribs 102 and103 at proximally projecting lateral corners 108 so as to facilitateforcing of the proximally projecting lateral corners 108 to approximateeach other when the urological implant 100 is pulled proximally fromimplant extraction handle 104 against the extraction sheath edge.

Each of first and second longitudinal ribs 102 and 103 is curved andincludes a proximal rib end 110 joined to a proximal end 111 of spinemember 101, a distal rib end 112 joined to a distal end 113 of spinemember 101, and an rib edge portion 114 provided between each pair ofcorresponding proximal and distal rib ends 110 and 112. Rib edge portion114 is sized and shaped for positioning in a correspondingposterolateral interlobar groove, when spine member 101 is positioned inand along an anterior interlobar groove 201 in prostatic urethra 200.

Implant extraction handle 104 is shaped to correspond an outline formedby proximal rib ends 110 along a proximal portion 115 of first andsecond longitudinal ribs 102 and 103.

FIGS. 3A-3F show various scenarios representing stages in an exemplarymethod of extracting urological implant 100. Urological implant 100 istethered at a distal portion 116 thereof, using an elastic tether 202,representing and modeling normal machinal resistance exerted from wallsof a prostatic urethra during withdrawal of implant 100.

FIG. 3A shows positioning an edge 301 of an extraction sheath 300 inproximity to proximal end 115 of urological implant 100, as in case ofpositioning thereof in the prostatic urethra.

FIG. 3B show applying of a fastening (gripping) device 302 to emergefrom extraction sheath 300 distally (simulating emerging into theprostatic urethra).

FIG. 3C show fastener 302 gripping (fastening) onto a mid-portion ofimplant extraction handle 104, and pulling of urological implant 100proximally from implant extraction handle 104.

FIG. 3D shows urological implant 100 pulled against edge 301, then it isforced to recollapse (FIG. 3E) until reaching the collapsed stateallowing it to be further withdrawn into lumen 303 of extraction sheath300 (FIG. 3F).

As shown, pulling of urological implant 100 (when under mechanicalresistance from prostatic urethra walls, for example) deforms implantextraction handle 104 such that deformation stresses developedthereinside force first and second longitudinal ribs 102 and 103 toapproximate one to other until reaching the collapsed state.

Each of the following terms written in singular grammatical form: ‘a’,‘an’, and ‘the’, as used herein, means ‘at least one’, or ‘one or more’.Use of the phrase ‘one or more’ herein does not alter this intendedmeaning of ‘a’, ‘an’, or ‘the’. Accordingly, the terms ‘a’, ‘an’, and‘the’, as used herein, may also refer to, and encompass, a plurality ofthe stated entity or object, unless otherwise specifically defined orstated herein, or, unless the context clearly dictates otherwise. Forexample, the phrases: ‘a unit’, ‘a device’, ‘an assembly’, ‘amechanism’, ‘a component’, ‘an element’, and ‘a step or procedure’, asused herein, may also refer to, and encompass, a plurality of units, aplurality of devices, a plurality of assemblies, a plurality ofmechanisms, a plurality of components, a plurality of elements, and, aplurality of steps or procedures, respectively.

Each of the following terms: ‘includes’, ‘including’, ‘has’, ‘having’,‘comprises’, and ‘comprising’, and, their linguistic/grammaticalvariants, derivatives, or/and conjugates, as used herein, means‘including, but not limited to’, and is to be taken as specifying thestated component(s), feature(s), characteristic(s), parameter(s),integer(s), or step(s), and does not preclude addition of one or moreadditional component(s), feature(s), characteristic(s), parameter(s),integer(s), step(s), or groups thereof. Each of these terms isconsidered equivalent in meaning to the phrase ‘consisting essentiallyof’.

FIGS. 4A-4D schematically illustrate views of an exemplary urologicalimplant 400 having two spaced arches. FIG. 4A shows side view of implant400 when it is implanted in a portion of the prostatic urethra adjacentto the bladder neck with it cranial end 401 thereof, and in proximity toopening of the ejaculatory duct to the prostatic urethra with caudal end402 thereof. Implant 400 may be sized to extend along entire length ofthe prostatic urethra, or only part thereof (for example, extending froma portion adjacently-caudally from the bladder neck, to a portionadjacently-cranially to the opening of the ejaculatory duct. Implant 400is optionally shaped and configured to be supported against bodilyprotrusion which constricts the prostatic urethra opening to the bladderneck. Implant 400 includes an elongated implant body 403 having alongitudinal axis 404. Longitudinal axis 404 is perpendicular to atransverse plane 405 and extending between cranial end 401 and caudalend 402 along a median plane 406 dividing implant body 403 into twosymmetrical halves.

Implant body 403 includes longitudinally spaced arched members,including a caudal-most arch member 407 and a cranial-most arch member408, each including an unsupported arch apex 409 located between a firstarch end 410 and a second arch end 411, forming together an archedmember plane being perpendicular to median plane 406, including acranial-most arched member plane 412 a, formed by arch apex 409 andfirst and second arch ends 410 and 11 of cranial-most arched member 407,and a caudal-most arched member plane 412 b, formed by arch apex 409 andfirst and second arch ends 410 and 11 of caudal-most arched member 408.Distance between each two closest arch apexes 409 is optionally within arange of 5 mm and 15 mm.

Arched members 407 and 408 are interconnected via arch ends thereof suchthat first arch ends 410 are connected sequentially along a length of afirst longitudinal rib portion 413, and second arch ends 411 areconnected sequentially along a length of a second longitudinal ribportion 414. Each of first and second longitudinal rib portions 413 and414 extends through transverse plane 405.

As illustrated in FIG. 4D, each one of arched members 407 and 408 iselastically bendable so as to facilitate elastic contractibility ofimplant body 403 when subjected to a transverse compressive force TFcrossing median plane 406. Implant body 403 is sized and configured toretract or/and support an anterior portion of the prostatic urethrawall, and allowing collapse of an unsupported posterior portion of theprostatic urethra wall opposing the anterior portion. Optionally andadditionally, implant body 403 is sized and configured so as tofacilitate physical resistance of the collapsed unsupported posteriorportion to a retrograde flow of semen from flowing therethrough towardsthe bladder neck.

The intersection of transverse plane 405 and a cranial-most archedmember plane 412 a forms a cranial-most angle β within a range of 20 to40 degrees. The intersection of transverse plane 405 and caudal-mostarched member plane 412 b forms a caudal-most angle α within a range of10 to 50 degrees.

FIGS. 5A-5C schematically illustrate views of an exemplary variation400′ of urological implant 400, which is similar or identical instructure and function to previous variation shown in FIGS. 2 , butwhich further includes two lateral spacers—a first lateral spacer 415emerging from first longitudinal rib portion 413 and a second lateralspacer 416 emerging from second longitudinal rib portion 414. Thelateral spacers are independently contractible when subjected to asagittal compressive force SF parallel to median plane 406.

Each one of the first and second lateral spacers includes a support ribportion 417 curved to resemble curvature of posterior surface of theprostatic urethra. A first of the support rib portions 417 isinterconnected with first longitudinal rib portion 413, and a second ofsupport rib portions 417 is interconnected with second longitudinal rib414, via an at least one support connecting portion including a firstsupport connection portion 418 and a second support connection portion419. Support rib portion 417 and/or support connecting portions 418 and419 are elastically bendable so as to facilitate elastic contractibilityof lateral spacers 415 and 416, as schematically illustrated in FIG. 5C,which facilitates recoverable approximation support rib portion 417 to acorresponding one of first and second longitudinal rib portions, 413 and414, when subjected to sagittal compressive force SF.

Each one of first and second lateral spacers 415 and 416 forms a closedfigure with first or second support rib portions 417 and first or secondlongitudinal rib portions, 413 or 414, respectively and first and secondsupport connection portions 418 and 419. The closed figure encloses acontact surface configured for retracting or/and supporting theprostatic urethra wall. Optionally, the closed figure resembles ameniscus lens shape with first and second support rib portions 417contoured as a convex, and first and second longitudinal rib portions413 and 414 contoured as a concave, of the meniscus lens shape. Theclosed figure is formed of a thin strip which incorporates supportconnecting portions 418 and 419, first or second support rib portion 417and first or second longitudinal rib portion 413 or 414.

Each one of first and second longitudinal rib portions 413 and 414 formsa first upper corner 420 with first support connecting portion 418 and asecond upper corner 421 with second support connecting portion 419,wherein caudal-most arched member 408 extends between respective firstupper corners 420, and cranial-most arched member 407 extends betweenrespective second upper corners 421.

FIGS. 6A-6C illustrate views of an exemplary urological implant 500 forretracting or/and supporting a prostatic urethra wall. Implant 500includes an elongated implant body 501 having a longitudinal axis 502,which is perpendicular to a transverse plane 503 and extends between acranial end 504 and a caudal end 505 of implant body 501 along a medianplane 506 dividing implant body 501 into two symmetrical halves.

Implant body 501 incorporates longitudinally spaced arched members,including a caudal-most arched member 507, a cranial-most arched member508 and an intermediate arch member 509. Each arched member includes anunsupported arch apex 510 located between a first arch end 511 and asecond arch end 512, forming together an arched member plane beingperpendicular to median plane 506. Each of the arched members isunsupported or interconnected along its length, including with apex 510,but only via arch ends thereof such that first arch ends 511 areconnected sequentially along a length of a first longitudinal ribportion 513, and second arch ends 512 are connected sequentially along alength of a second longitudinal rib portion 514; both first and secondlongitudinal rib portions 513 and 514 extend through transverse plane503. The distance between each two closest of arch apexes 510 is withina range of 5 mm and 15 mm.

Each one of arched members 507, 508 and 509 is elastically bendableabout longitudinal axis 502 so as to facilitate elastic contractibilityof implant body 501 when it is subjected to a transverse compressiveforce crossing median plane 506. Implant body 501 is sized andconfigured to retract or/and support an anterior portion of theprostatic urethra wall, thereby allowing collapse of an unsupportedposterior portion of the prostatic urethra wall opposing said anteriorportion, and to facilitate physical resistance of the collapsedunsupported posterior portion to a retrograde flow of semen from flowingtherethrough towards the bladder neck.

The intersection of transverse plane 503 and a cranial-most archedmember plane 515, formed by arch apex 510 and first and second arch ends511 and 512 of cranial-most arched member 508, forms a cranial-mostangle β within a range of 20 to 40 degrees. The intersection oftransverse plane 503 and a caudal-most arched member plane 516, formedby arch apex 510 and first and second arch ends 511 and 512 ofcaudal-most arched member 507, forms a caudal-most angle α within arange of 10 to 50 degrees. The arch apex 510 and first and second archends 511 and 512 of intermediate arch member 509 forms an intermediatearched member plane being parallel to transverse plane 503.

A first lateral spacer 517 emerges from first longitudinal rib 513 and asecond lateral spacer 518 emerges from second longitudinal rib 514, eachis individually contractible when subjected to a sagittal compressiveforce parallel to median plane 506. First and second lateral spacers 517and 518 are configured to approximate each other towards median plane506 when arched members are bent about longitudinal axis 502 and implantbody 501 is contracted. First lateral spacer 517 includes a firstsupport rib portion 519 interconnected with first longitudinal ribportion 513, and second lateral spacer 518 includes a second support ribportion 520 interconnected with second longitudinal rib 514, via a firstsupport connecting portion 521 and a second support connecting portionand 522. Support rib portions 519 and 520 and/or support connectingportions 521 and 522 are elastically bendable so as to facilitate saidelastic contractibility of lateral spacers 517 and 518, wherein elasticcontractibility of first and second lateral spacers 517 and 518facilitates recoverable approximation support rib portion 519 and 520 toa respective (first or second) longitudinal rib portion (513 or 514)when subjected to sagittal compressive force.

Each of first and second lateral spacers 517 and 518 forms a closedfigure with its respective support rib portions and longitudinal ribportion, together with first and support connecting portions 521 and522. The closed figure encloses a contact surface configured forretracting or/and supporting the prostatic urethra wall and resembles ameniscus lens shape with support rib portions 519 and 520 contoured as aconvex, and first and second longitudinal rib portions 513 and 514contoured as a concave, of the meniscus lens shape. The closed figure isformed of a thin strip which incorporates its respective supportconnecting portions, support rib portion and longitudinal rib portion.

Each one of first and second longitudinal rib portions 513 and 514 formsa first upper corner 523 with first support connecting portion 521 and asecond upper corner 524 with second support connecting portion 522.Cranial-most arched member 508 extends between corresponding first uppercorner 523, and caudal-most arched member 507 extends betweencorresponding second upper corner 524.

Arch apex 510 in each arch member is located above, and directed awayfrom, first and second longitudinal rib portions 513 and 514 relative tolongitudinal axis 502, such that when the implant supports the prostaticurethra wall, arch apex 510 is located adjacent midline of an anteriorportion of the prostatic urethra wall and first and second longitudinalrib portions 513 and 514 are positioned closer to a posterior portion ofthe prostatic urethra wall.

Implant body 501 has a total height H in an anterior direction within arange of 10 mm to 40 mm and a width W in a lateral direction within arange of 8 mm to 30 mm, when in a relaxed not collapsed configuration(as shown in FIGS. 6A-6C). Arched members form a nominal angle within arange of 0 to 60 degrees along their corresponding arched member plane,when implant body 501 is in a relaxed not collapsed configuration.Implant body 501 is configured to apply a contraction resistive force ofat least 100 grf when the arched members are forced into a compressedangle smaller than their nominal angle by at least 20%, therebyretracting or/and supporting the prostatic urethra wall so as to form ata chosen nominal opening size across the prostatic urethra. The chosennominal opening size has optionally a cross section area of at least 10mm square.

Implant 500 further includes an implant extraction handle 525 providedcaudally distant to implant body 501 and symmetrically connected at oneside 526 thereof to first lateral spacer 517 and at a second side 527thereof to second lateral spacer 518. Implant extraction handle 525 mayalso be considered a caudal-most arched connection member. Implantextraction handle 525 is shaped to correspond an outline of theurological implant 500 formed by first and second lateral spacers 517and 518 with an extraction handle apex 528 thereof provided adjacent toarch apex 510 of caudal-most arched member 507, and is configured toshift elastically, when under a pulling force PL (as schematicallyillustrated in dotted line in FIG. 6B) originating therefrom, such thatextraction handle apex 528 points in a caudal direction towards and/oralong longitudinal axis 502 and away from arch apex 510 of caudal-mostarched member 507.

Implant extraction handle 525 is configured to contract first and secondlateral spacers 517 and 518, when the implant 500 is pulled caudallyvia/from implant extraction handle 525, optionally against a counteringsurface, such as an edge of a retraction sheath enclosing a lumen sizedto accommodate the implant therein when it is in a collapsed state.

Each of first and second support rib portions 519 and 520 forms a lowercorner 529 with a respective caudal-most support connection portion 522,wherein implant extraction handle 525 is connected at one side 526thereof to one of the lower corners 529 at first lateral spacer 517 andat second side 527 thereof to another of the lower corners 529 at secondlateral spacer 518.

The present invention further describes a method for supporting or/andextracting a wall of a partially constricted prostatic urethra, byapplying urological implant of the present invention such as implant 400(optionally particularly variation 400′ thereof) or implant 500. Themethod includes at least one of the following steps, not necessarily insame order:

-   -   contracting implant body 401/501 from a relaxed noncontracted        configuration by way of elastically bending arched members 407 &        408/507, 508 & 509 and approximating first and second        longitudinal rib portions 413 & 414/513 & 514 together.    -   positioning implant 400/500 in the partially constricted        prostatic urethra with implant body 401/501 contracted into a        chosen contracted size and shape configured for atraumatic        insertion in the partially constricted prostatic urethra,        wherein each arch apex 409/510 is located adjacent midline of an        anterior portion of the prostatic urethra wall;    -   releasing implant body 401/501 thereby allowing arched members        407 & 408/507, 508 & 509 to autonomously shift first and second        longitudinal rib portions 413 & 414/513 & 514 away from each        other relative to median plane 406/506, to contact the wall of        the partially constricted prostatic urethra and to retract the        prostatic urethra by pressing against the prostatic urethra        wall. The step of releasing may include retracting or/and        supporting an anterior portion of the prostatic urethra wall,        and allowing collapse of an unsupported posterior portion of the        prostatic urethra wall opposing said anterior portion. The step        of releasing may also include allowing the implant body to        facilitate physical resistance of the collapsed unsupported        posterior portion to a retrograde flow of semen from flowing        therethrough towards the bladder neck.

The chosen contracted size is optionally resulted also from elasticallybending at least one of support rib portions 417/519 and 520 and supportconnecting portions 418 & 419/521 & 522 by way of approximating supportrib portion to a corresponding first or second longitudinal rib portion,optionally resulted from forces applied to the support rib portion fromthe prostatic urethra wall during said positioning.

FIG. 7 is a flow chart illustration of method for extracting aurological implant in accordance with an embodiment of the currentinvention. In some embodiments, a urological implant includes anextraction handle. Optionally, the implant is provided in a relaxedstate (for example as illustrated in FIGS. 1E, 1F, 2, 3A, 3B and 8 ).For example, the implant may be expanded inside a urethra to supportperiurethral tissue and/or to hold open a urethra. Optionally pulling755 the extraction handle proximally with respect to the implant bodycauses the implant to collapse 757 (for example as illustrated in FIGS.3C and 8 ). For example, the ribs may collapse 757 approximately towardsa longitudinal axis of the device and/or away from the walls of theurethra. In some embodiments, the extraction handle may be pulled 755 bya fastener into a sheath (e.g. a catheter). Optionally, as the device ispulled the extraction handle may take a wedge shape with an apex facingthe sheath. For example, as the handle is pulled 755 into the sheath theangled sides of the handle may be pushed together by the inner walls ofthe sheath further collapsing 759 the handle. Optionally the sides ofthe handle are connected to the ribs of the implant and/or furthercollapsing 759 the handle further collapses 757 the ribs of the implantfacilitating drawing the implant into the sheath.

FIG. 8 is a block diagram of a urological implant system in accordancewith an embodiment of the current invention. In some embodiments, animplant includes a connecting member 808, for example an arch and/or aspine. Optionally, the connecting member 808 connects to one or morelongitudinal ribs 802, 803. The ribs 802, 803 optionally spread awayfrom each other (for example laterally away from a longitudinal axis ofbody) to a support tissue in a urethra. Optionally the ribs 802, 803and/or the connecting member 808 are attached to an extraction handle804. For example, the extraction handle 804 may be positioned proximallyto the connecting member 808. In some embodiments, when the extractionhandle 804 is pulled proximally, ribs 802, 803 contract towards eachother (for example laterally towards a longitudinal axis of body). Forexample, contraction may make it easier to extract the device from aurethra. Optionally, the implant and/or the extraction handle 804 mayinclude a wedge 886 and/or an apex 888. For example, pulling extractionhandle 804 and/or the apex 888 proximally positions the apex 888proximal to the implant. Optionally pulling the implant and/or theextraction handle 804 and/or the apex 888 proximally into an extractionsheath 880 pulls the wedge 886 into the sheath 880. For example, bypulling the wedge 886 into the sheath 880, the walls of the sheath 880may push inward against the wedge 886 thereby further collapsing theimplant laterally inward. For example, the ribs 802, 803 may collapsetowards the longitudinal axis of the body 801. For example, a distal endof the sheath 880 may be positioned proximal to the implant and/or afastener 882 may be passed out a distal end of the extraction sheath880. Optionally the fastener 882 may be passed through the sheath 880from a proximal end thereof. The fastener 882 may be fastened to theextraction handle 804 and/or pulled proximally into the extractionsheath 880 to pull the extraction handle 804 and/or collapse the implantand/or draw the wedge 886 into the sheath 880 and/or draw the wholeimplant into the sheath 880.

FIG. 9 is a perspective view of a three arched urological implant in anexpanded state accordance with an embodiment of the current invention.The exemplary device includes three arched members. For example, aproximal most arch includes an extraction handle 904 and/or two distalarches 908 a and 908 b include connecting members. Optionally, theproximal arch (handle 904) also includes a connecting member. Forexample, handle 904 and/or connecting members 908 a, 908 b connectbetween two longitudinal ribs 901. Optionally, each longitudinal rib 901may have a closed form. For example, the closed form may include analmond shape (for example with two pointed ends). For example, thealmond shape may facilitate collapsing the device. Alternatively oradditionally, the closed form may include an oval and/or a rectangleand/or a parallelogram and/or an almond shape with one point and/or acurve (for example, the rib with one or more of the arches may form awedge shape (e.g. pie shape)) and/or another form. Optionally, thedevice is biased to the expanded state and/or is relaxed in the expandedstate.

In some embodiments, the device is configured to inhibit the device frommoving into the bladder. For example, distalmost arch 908 a and/or anintermediate arch 908 a and/or handle 904 tilts distally. Optionally,when the implant is in place in the prostatic Urethra with the distalend of the device facing the bladder (e.g. the proximal end of theimplant facing caudally and/or the distal end facing cranially) thedistal tilt of the arches prevents the device from migrating distallytowards the bladder. For example, forcing the device distally causes thearches to straighten and/or dig into the wall of the urethra, inhibitingdistal migration of the device. Optionally, different connecting membersmay be inclined in different directions. For example, as illustrated inFIG. 6A a distal connector 508 may be inclined proximally and/or aproximal connector 507 may be inclined distally and/or an intermediateconnector 509 may be directed perpendicular to a rib 514.

In some embodiments, a connecting member may include a bend and/or fold(e.g. each of arches 908 a, 908 b and handle 904 include a U-shaped fold991 in its center along the axis of the device). For example, the fold991 may make the device more flexible and/or facilitate collapsing thedevice. In some embodiments, the ribs and/or arches are configured toflexible enough to fit into different sized urethras. For example, thealmond shape of the ribs and/or the fold 991 of the connecting membersmay increase the flexibility of the device. For example, a device may beflexible enough to fit in a Urethra having a width of between 6 to 11mm.

In some embodiments, handle 904 is configured to me more easily bentthan one or more of the other arches 908 a, 908 b. For example, handle904 may be made of thinner material (for example between 0 to 10%thinner and/or between 10 to 50% thinner and/or between 50 to 80%thinner, for example the material of the arches may be between 0.4 to0.6 mm and/or the thickness of the material of the handle may be between0.2 to 0.4 mm).

In some embodiments, flexibility of a handle may be enhanced bydirection of a joint and/or by its curvature. for example, handle 904 isconnected to rib 901 with a joint that points approximately proximallyand then handle 904 curves distally. For example, at the joint of handle904 and rib 901, the handle points more distally than the direction aarches 908 a and 908 b where they join rib 901. For example, handle 904include more curvature than arches 908 a and 908 b.

In some embodiments, the distal most connector 908 a is positions toavoid impinging on a bladder of a subject. For example, connector 908 amay be connected to a proximal portion of rib 901 (for example distal to50% of the length of rib 901 and/or body of the device and/or distal to25% of the length of the device). Optionally, the arches 908 a, 908 band/or handle 904 are configured to remain proximal of the distal end ofrib 901 in the expanded configuration (for example as illustrated inFIGS. 9 and 10 ) and/or in the collapsed configuration (for example asillustrated in FIGS. 11 and 12 and/or as illustrated for example bydistal connector 1308 a of FIG. 13 ). Alternatively or additionally, aconnecting member (e.g. an arch and/or arches) may extend distal to one,some and/or all of the ribs in one or both of the collapsed states (e.g.the collapsed state for insertion and/or the collapsed state forextraction) but not in the expanded state. Alternatively oradditionally, in some embodiments, a connecting member may extend distalto one, some or all of the ribs in the expanded state and/or in theexpanded and collapsed state.

FIG. 10 is a bird's eye view of a three arched urological implant in anexpanded state in accordance with an embodiment of the currentinvention.

FIG. 11 is a side view of a three arched urological implant in acollapsed state for insertion into a urethra in accordance with anembodiment of the current invention. For example, before insertion intoa subject the device is collapsed into an insertion state and insertedinto a catheter 980. Optionally, in an insertion configuration handle904 is folded distally towards the body of the device (e.g. towards ribs901 and/or arches 908 a, 908 b). Optionally, in the insertionsconfiguration handle 904 is folded in the same direction of one, some orall of arches 908 a, 908 b.

FIG. 12 is a bird's eye view of a three arched urological implant in acollapsed state for insertion into a urethra in accordance with anembodiment of the current invention.

FIG. 13 is a side view of a four arched urological implant 1301 in acollapsed state for extraction from a urethra in accordance with anembodiment of the current invention. For example, when extractingimplant 1301, an extraction handle 1304 is pulled proximally. Pullingextraction handle 1304 proximally and/or pulling the device into asheath 980 optionally causes the implant 1301 to collapse (for example,as described in FIGS. 3A-3F, 7 and 8 ). Collapsing the implant 1301optionally facilitates pulling the device into the sheath 980 and/orextracting the device from the Urethra and/or repositioning the devicefrom the Urethra. In some embodiments, in the extraction collapsed statehandle 1304 is pulled proximally and/or connecting members (e.g. distalarch 1308 a, intermediate arch 1308 b and/or proximal arch 1308 c) allfold distally and/or the body of the device (for example including rib1301) collapses inward.

In some embodiments, different sized implants may be available. Forexample, a four arched implant 1301 may be larger than a three archedimplant 901.

FIG. 14 illustrates 4 sizes of implants a large implant 1400 a, amedium-large implant 1400 b, a medium implant 1400 c and a small implant1400 d in accordance with embodiments of the current invention. In someembodiments, a larger implant may have more connecting arches than asmall implant. For example, large implant 1400 a includes five archeswhereas the medium-large implant 1400 b, the medium implant 1400 b, andthe small implant 1400 a each includes four arches. Optionally,proportions of the devices are fixed. For example, the ratio of lengthto width and/or length to height is approximately the same for each sizeof the device. Optionally, for each device the height and/or width ofthe distal side of the device is less than the proximal side.

In many cases, the prostate urethra in grows proportionally in all thesedimensions, in This may contrast with other tubular structures (forexample some blood vessels). Optionally the urethral implant will havesimilar proportions, for example, in order to fit snugly in the prostateurethra and/or to be in intimate contact with the prostate urethramucosa and/or to be covered by it.

FIG. 15 illustrates a distal (e.g. cranial) end view of a flat implantblank before folding in accordance with an embodiment of the currentinvention. For example, the device may be cut out from a sheet ofmaterial. For example, the material may include approximately 0.5 mmthick 1571 nitinol and/or another alloy and/or another material (forexample a polymer and/or a composite). Alternatively or additionally,the thickness may range between 0.2 to 1.0 mm and/or between 1 to 3 mm.

FIG. 16 is an anterior view of a flat implant blank after cutting and/orbefore folding in accordance with an embodiment of the currentinvention. The during production of the implant, the structure isoptionally cut into the flat blank of material leaving a 2D pattern forexample as illustrated in the FIG. 16 . For example, the shape may becut to include two lateral spacers configured as retractors forretracting posterior lateral walls of the prostatic urethra. Forexample, each retractor may be formed with a closed form having alongitudinal rib 1601. Optionally, the retractors are connected byconnecting members 1608 a, 1608 b and/or 1608 c and/or an extractionhandle 1604. Optionally extraction handle 1604 is a proximal-mostconnecting member. For example, the extraction handle 1604 may connectproximal portions of the retractors and/or proximal protrusion (e.g.lower corners 1629) of the implant. Optionally, each retractor includesa distal protrusion (e.g. upper corners 1624). Optionally, some or allof the connecting members 1608 a, 1608 b, 1608 c and/or handle 1604 mayinclude a central apex 1691. For example, the apex 1691 may include afold in the connecting member 1608 a, 1608 b, 1608 c and/or handle 1604.For example, a central portion of the connecting member may be folded inan anterior and/or cranial direction.

In some embodiments, the parts of the device may be formed of wire likeforms. Optionally, the width of the various parts may vary. For example,all or some of all the connecting members 1608 a, 1608 b, 1608 c mayhave a width 1677, 1675, 1674 that is greater than the width 1678 ofhandle 1604 device. Optionally, widths 1677, 1675, 1674 of theconnecting members 1608 a, 1608 b, 1608 c may vary. For example, theratio of the width 1678 of the of the handle 1604 (which may beconsidered the proximal-most connecting member) to the width 1674 of thedistal connecting member 1608 a may range between 1:1 to 0.9:1 and/orbetween 0.9:1 to 0.6:1. Optionally, the connecting members mayprogressively widen as one move distally. For example, the width 1676 ofthe longitudinal rib 1601 may be approximately equal to the width 1675of the distal handle 1674.

In some embodiment, in the flattened device, the lateral retractors mayopen in a distal direction. For example, the angle 1673 between the axesof the opposite lateral retractors may range between 18 to 22 degreeand/or between 15 to 18 degrees and/or between 10 to 15 degrees and/orbetween 22 to 25 degrees and/or between 25 to 30 degrees. For example,the angle 1680 between tangents on lateral edges of the opposite lateralretractors may range between 22 to 28 degree and/or between 15 to 22degrees and/or between 10 to 15 degrees and/or between 28 to 30 degreesand/or between 30 to 35 degrees.

In some embodiments, the ratio of the length 1679 of the flatteneddevice to its width 1572 may range between 0.54 to 0.6 and/or between0.4 to 0.54 and/or between 0.6 to 0.7 and/or between 0.2 to 0.4 and/orbetween 0.7 to 1.0.

FIG. 17 illustrates folding of an implant in accordance with anembodiment of the current invention. For example, the view of FIG. 17 isa cranial orthogonal view. For example, the flat device blank may befolded to an angle 1782 spanning approximately 70 degrees with an apexat the center of the connecting members 1608 a, 1608 b, 1608 c and/orhandle 1604. For example, the apex may be rounded for example, byfolding over a cylindrical and/or conical jig 1792. For example, the jigmay have a radius 1783 of approximately 16 mm. Optionally, the foldingwill form the connecting members 1608 a, 1608 b, 1608 c and/or handle1604 into arches for example as illustrated in FIG. 14 and/or FIG. 9 .

In some embodiments, after folding, the ratio of the lateral width 1788between the posterior ends of the retractors 1601 to the average height1781 of the folded implant (e.g. the average height of the apexes ofconnecting members 1608 a, 1608 b, 1608 c and extraction handle 1604)may range between 1.2 to 1.6 and/or between 0.8 to 1.2 and/or between1.6 and 2 and/or between 2 and 3.

FIG. 18A is a lateral orthogonal view of an implant in accordance withIn some embodiments of the current invention. For example, the height ofthe arches (e.g. connecting members 1608 a, 1608 b, 1608 c and/or handle1604) of the implant may increase as one moves towards the distal end ofthe device). For example, the highest arch of the implant may be thedistal connecting member 1608 a and/or the shortest arch may be theproximal handle 1604. For example, the ratio of height 1885 of thehighest arch (e.g. rib 1608 a) to the height 1886 of the shortest arch(e.g. handle 1604) may range between 1.1:1 to 1.4:1 and/or between 1:1to 1.1:1 and/or between 1.4:1 to 2:1. In some embodiments, the heightsof the arches may decrease approximately linearly from the distal end tothe proximal end of the implant.

In some embodiments, the apex 1691 of each arch (for example a fold) istipped distally. For example, the distally tipped apex 1691 may catchalong the anterior side of the urethra and/or prevent cranial migrationof the implant in the urethra). For example, the ratio of the height1886 of an arch (e.g. the handle 1604) with the fold to the height 1887without the fold may range between 1.02:1 to 1.06:1 and/or between 1:1to 1.02:1 and/or between 1.06:1 to 1.1:1. In some embodiments, theanterior tip of an arch is distal of the connection between the arch andthe retractor. Optionally, an arch (for example, the distal connectingmember 1608 a from its point of connection with the retractor to itsapex 1691) may be angled distally with respect to a longitudinal axis ofthe retractor at an angle 1889 ranging between 50 to 85 degrees and/orbetween 30 to 50 degrees. In some embodiments, the ratio of averageheight 1781 to length 1884 of an implant may range between 0.6 to 0.65and/or between 0.4 to 0.6 and/or to between 0.65 to 0.8 and/or between0.2 to 0.4 and/or between 0.8 to 1.

In some embodiments, there may be various sizes of implants. Optionallythe various sized implants will have some or all of the same relativemeasurements (for example the ratio of length 1884 to height 1885 of thedistal connecting member 1608 a and/or handle 1604 etc.). For example, alarge implant 1400 a may have a length 1884 of approximately 40 mmand/or a medium large implant 1400 b may have a length 1884 ofapproximately 34 mm and/or a medium implant 1400 c may have a length1884 of approximately 30 mm and/or a small implant 1400 c may have alength 1884 of approximately 23 mm.

FIG. 18B is a axial view of an implant in accordance with an embodimentof the current invention. Optionally, the body of the implant defined alongitudinal channel 1891 (an exemplary axial projection thereof isillustrated by the dotted area of FIG. 18B). Optionally the channel isopen on one side (e.g. the posterior side). For example, the lateralsides of the channel may be determined by lateral retractors 1691 and/orthe height of the channel may be determined by the distance from an apexof the lowest connecting member (e.g. handle 1604) to the base of thelateral retractors 1691. Optionally, a lateral axis is defined by and/orparallel to a line 1803 joining cranial protrusions 1624. A median plane1806 is optionally defined perpendicular to and/or bisecting line 1803.In some embodiments, a line 1803 is not centered along the height (e.g.the anterior-posterior dimension) of channel 1891. For example, alongmedian plane 1806 line 1803 may be in the posterior ½ and/or posterior ⅓and/or posterior ¼ of the channel. In some embodiments, the channel 1891is wider on its posterior side than its anterior side. For example, theanterior side of the channel may form an apex. For example, the anteriorside of the channel 1891 may for an apex.

In some embodiments, a device will have cranial protrusions 1624 on theposterolateral sides. For example, these protrusions 1624 will impedecranial drift of the implant, for example by resting on a ledge formednear the bladder neck. For example, the lateral distance between thecranial posterolateral will be greater than the lateral extent of theimplant on its proximal end. For example, the ratio between the lateralwidth of the implant at the a caudal end portion to the width betweenprotrusions 1624 may range between 99/100 to 90/100 and/or 90/100 to80/100 and/or 80/100 to 60/100 and/or between 60/100 to 40/100 and/orbetween 40/100 to 10/100. For example, the ratio of axial length of theimplant to width between the cranial posterolateral protrusions mayrange between 50/100 to 75/100 and/or 75/100 to 90/100 and/or 90/100 to1/1 and/or 1/1 to 110/100 and/or 110/100 to 125/100 and/or 125/100 to150/100 and/or 150/100 to 200/100 and/or 200/100 to 300/100.

In some embodiments, the implant is configured to fit a prostate urethrawhose diameter is larger at the cranial side near the bladder neck thanat the caudal side near the VERUM MONTANUM or coliculi seminalae.

FIG. 19 is a cranial posterior view of a tubular implant in accordancewith an embodiment of the current invention. In some embodiments, theimplant may have perforated walls and/or be constructed of a metaland/or wire mesh, for example, similar to a a stent. Alternatively oradditionally, the walls of the implant may be solid and/or include apolymer and/or have a covering. In some embodiments, an implant 1900 mayhave a tubular form. Optionally, posterolateral cranial projections 1924are included on a cranial/distal end of the device. For example, implant1900 has the form of a right cylinder with circular cross sections. Aclosed circular channel 1991 passes through the implant from its caudalend to its cranial end. For example, at point posterior to a centralaxis of the channel 1991, projections 1924 project cranially surroundingwalls of the channel 1991. Optionally, the cranial projections 1924 arepositioned on opposite lateral sides of the channel 1991. For example,the protrusions 1924 are configured to rest on the wall of the urethraon opposites sides of a bladder neck and/or outside the bladder and/oron the urethra side of the bladder neck and/or to stretch the bladderneck laterally and/or to for a ledge and/or to rest on a ledge at thebladder neck. For example, this may prevent the implant from migratingcranially through the bladder neck into the bladder. Optionally, thelateral walls of channel 1991 form lateral retractors 1901. For example,the lateral sides may hold open the lateral walls of a prostaticurethra. Optionally, an anterior apex 1908 and/or a posterior wall 1907of the cylinder form an anterior/posterior retractor. For example, theanterior/posterior retractor may be configured to retract the anteriorand/or posterior walls of the urethra. In some embodiments, the implantmay collapse and/or expand, for example for insertion into the urethravia a catheter.

FIG. 20 is a cranial posterior view of a tubular implant in accordancewith an embodiment of the current invention. In some embodiments, animplant 2000 may have a tapered tubular form. In some embodiments, theimplant may have perforated walls and/or be constructed of a metaland/or wire mesh, for example, similar to a a stent. Alternatively oradditionally, the walls of the implant may be solid and/or include apolymer and/or have a covering. Optionally, posterolateral cranialprojections 2024 are included on a cranial/distal end of the device.Optionally, the cranial end of the device is wider than the caudal andand/or the device is tapers caudally. Optionally, the projections 2024spread cranially. The taper of implant 2000 and/or the craniallyspreading of projections 2024 is seen clearly in the orthogonal view ofFIG. 23 . For example, implant 2000 has the form of a tapered rightcylinder with a circular cross section. Alternatively or additionally,an insert may have a different cross section, for example, triangularand/or square etc. A closed circular channel 2091 passes through theimplant from its caudal end to its cranial end. For example, at pointposterior to a central axis of the channel 2091, projections 2024project cranially surrounding walls of the channel 2091. Optionally, thecranial projections 2024 are positioned on opposite lateral sides of thechannel 2091. For example, the protrusions 2024 are configured to reston the wall of the urethra on opposites sides of a bladder neck and/oroutside the bladder and/or on the urethra side of the bladder neckand/or to stretch the bladder neck laterally and/or to for a ledgeand/or to rest on a ledge at the bladder neck. For example, this mayprevent the implant from migrating cranially through the bladder neckinto the bladder. Optionally, the lateral walls of channel 2091 formlateral retractors 2001. For example, the lateral sides may hold openthe lateral walls of a prostatic urethra. Optionally, an anterior apex2008 and/or a posterior wall 2007 of the cylinder form ananterior/posterior retractor. For example, the anterior/posteriorretractor may be configured to retract the anterior and/or posteriorwalls of the urethra. In some embodiments, the implant may collapseand/or expand, for example for insertion into the urethra via acatheter.

FIG. 21 is a lateral cranial view of a tapered tubular implant inaccordance with an embodiment of the current invention.

FIG. 22 is a posterior cranial view of a tapered tubular implant inaccordance with an embodiment of the current invention.

FIG. 23 is a posterior orthogonal view of a tapered tubular implant inaccordance with an embodiment of the current invention. The dimensionsand/or proportions of the tubular implant 2000 are optionally in thesame range as those of the open sided implants described above.

Each of the phrases ‘consisting of’ and ‘consists of’, as used herein,means ‘including and limited to’. Optionally the extraction handle is ona proximal end thereof and/or proximal of the device.

The phrase ‘consisting essentially of’, as used herein, means that thestated entity or item (system, system unit, system sub-unit, device,assembly, sub-assembly, mechanism, structure, component, element, or,peripheral equipment, utility, accessory, or material, method orprocess, step or procedure, sub-step or sub-procedure), which is anentirety or part of an exemplary embodiment of the disclosed invention,or/and which is used for implementing an exemplary embodiment of thedisclosed invention, may include at least one additional ‘feature orcharacteristic’ being a system unit, system sub-unit, device, assembly,sub-assembly, mechanism, structure, component, or element, or,peripheral equipment, utility, accessory, or material, step orprocedure, sub-step or sub-procedure), but only if each such additional‘feature or characteristic’ does not materially alter the basic noveland inventive characteristics or special technical features, of theclaimed entity or item.

The term ‘method’, as used herein, refers to steps, procedures, manners,means, or/and techniques, for accomplishing a given task including, butnot limited to, those steps, procedures, manners, means, or/andtechniques, either known to, or readily developed from known steps,procedures, manners, means, or/and techniques, by practitioners in therelevant field(s) of the disclosed invention.

Throughout this disclosure, a numerical value of a parameter, feature,characteristic, object, or dimension, may be stated or described interms of a numerical range format. Such a numerical range format, asused herein, illustrates implementation of some exemplary embodiments ofthe invention, and does not inflexibly limit the scope of the exemplaryembodiments of the invention. Accordingly, a stated or describednumerical range also refers to, and encompasses, all possible sub-rangesand individual numerical values (where a numerical value may beexpressed as a whole, integral, or fractional number) within that statedor described numerical range. For example, a stated or describednumerical range ‘from 1 to 6’ also refers to, and encompasses, allpossible sub-ranges, such as ‘from 1 to 3’, ‘from 1 to 4’, ‘from 1 to5’, ‘from 2 to 4’, ‘from 2 to 6’, ‘from 3 to 6’, etc., and individualnumerical values, such as ‘1’, ‘1.3’, ‘2’, ‘2.8’, ‘3’, ‘3.5’, ‘4’,‘4.6’, ‘5’, ‘5.2’, and ‘6’, within the stated or described numericalrange of ‘from 1 to 6’. This applies regardless of the numericalbreadth, extent, or size, of the stated or described numerical range.

Throughout this disclosure, the term ‘proximal’ shall mean a location ina patient's body situated closest to entry point of a medical device orimplant, and the term ‘distal’ shall mean a location in a patient's bodysituated farthest from such entry point.

Moreover, for stating or describing a numerical range, the phrase ‘in arange of between about a first numerical value and about a secondnumerical value’, is considered equivalent to, and meaning the same as,the phrase ‘in a range of from about a first numerical value to about asecond numerical value’, and, thus, the two equivalently meaning phrasesmay be used interchangeably. For example, for stating or describing thenumerical range of room temperature, the phrase ‘room temperature refersto a temperature in a range of between about 20° C. and about 25° C.’,and is considered equivalent to, and meaning the same as, the phrase‘room temperature refers to a temperature in a range of from about 20°C. to about 25° C.’.

The term ‘about’ and approximately as used herein, refers to ±10% of thestated numerical value.

The phrase ‘operatively connected’, as used herein, equivalently refersto the corresponding synonymous phrases ‘operatively joined’, and‘operatively attached’, where the operative connection, operative joint,or operative attachment, is of a physical, or/and electrical, or/andelectronic, or/and mechanical, or/and electro-mechanical, manner ornature, involving various types and kinds of hardware or/and softwareequipment and components.

It is to be fully understood that certain aspects, characteristics, andfeatures, of the invention, which are, for clarity, illustrativelydescribed and presented in the context or format of a plurality ofseparate embodiments, may also be illustratively described and presentedin any suitable combination or sub-combination in the context or formatof a single embodiment. Conversely, various aspects, characteristics,and features, of the invention which are illustratively described andpresented in combination or sub-combination in the context or format ofa single embodiment, may also be illustratively described and presentedin the context or format of a plurality of separate embodiments.

Although the invention has been illustratively described and presentedby way of specific exemplary embodiments, and examples thereof, it isevident that many alternatives, modifications, or/and variations,thereof, will be apparent to those skilled in the art. Accordingly, itis intended that all such alternatives, modifications, or/andvariations, fall within the spirit of, and are encompassed by, the broadscope of the appended claims.

All publications, patents, and or/and patent applications, cited orreferred to in this disclosure are herein incorporated in their entiretyby reference into the specification, to the same extent as if eachindividual publication, patent, or/and patent application, wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis specification shall not be construed or understood as an admissionthat such reference represents or corresponds to prior art of thepresent invention. To the extent that section headings are used, theyshould not be construed as necessarily limiting.

What is claimed is:
 1. An implant for retracting or/and supporting aprostatic urethra wall, the implant having an elongated implant bodydefining a longitudinal channel having a longitudinal axis, extendingbetween a cranial end and a caudal end of said implant body; a medianplane including said longitudinal axis said median plane having ananterior-posterior axis perpendicular to said longitudinal axis; alateral axis perpendicular to said median plane and including a crossingpoint of said anterior-posterior axis and said longitudinal axis; a pairof posterolateral retractors located on opposite sides of said medianplane and posterior to said longitudinal axis; at least one cranialinterconnecting member connecting a respective cranial connection end oneach of said pair of posterolateral retractors to a cranial anteriorapex located on said median plane anterior to said pair ofposterolateral retractors, wherein in an unstressed configuration saidat least one cranial interconnecting member extends laterally andposteriorly from said cranial anterior apex to each said respectivecranial connection end; at least one caudal interconnecting memberconnecting a respective caudal connection end on each of said pair ofposterolateral retractors to a caudal anterior apex located on saidmedian plane caudal to said caudal anterior apex and anterior to saidpair of posterolateral retractors, wherein in an unstressedconfiguration said at least one caudal interconnecting member extendslaterally and posteriorly from said caudal anterior apex to each saidrespective caudal connection end wherein each said respective caudalconnection end is caudal to each said respective cranial connection end.2. The implant of claim 1, further comprising a pair of cranialprojections configured to rest on a ledge of a bladder neck therebypreventing cranial drift of the implant into a bladder.
 3. The implantof claim 2, wherein a lateral width said channel at side line betweensaid pair of cranial projections is greater than a lateral width of saidchannel at any location anterior thereto.
 4. The implant of claim 1,wherein said median plane divides said implant body into two symmetricallateral halves.
 5. The implant of claim 2, wherein one of said pair ofcranial projections projects in a cranial direction from each of saidposterolateral retractors beyond said cranial interconnecting member. 6.The implant of claim 2, wherein in said unstressed configuration, alateral width of said implant body between said pair of cranialprojections is greater than a lateral width of the implant body betweencaudal portions of said pair of posterolateral retractors.
 7. Theimplant of claim 2, where a ratio of a width of the channel betweencaudal portions of the pair of posterolateral retractors to the lateralwidth between the pair of cranial projections ranges between 9/10 to6/10.
 8. The implant of claim 1, wherein a height in an anteriordirection of the cranial apex from each said cranial connection end isgreater than a height in the anterior direction of the caudal apex fromcaudal connection end.
 9. The implant of claim 1, wherein each of saidat least one cranial connecting member and said at least one caudalconnecting member are elastically bendable so as to facilitate elasticcontractibility of said implant body when said implant body is subjectedto a transverse compressive force crossing said median plane.
 10. Theimplant of claim 1, wherein a ratio of a length of said implant in alongitudinal direction and an average anterior height of said cranialapex and said caudal apex from said pair of posterolateral retractorsranges between 12/10 to 16/10.
 11. The implant of claim 1, furthercomprising: wherein said at least one caudal connecting member isconfigured to shift elastically, under a pulling force away from said atleast one cranial connecting member to facilitate approximation of saidpair of posterolateral retractors relative to said longitudinal axis.12. The implant of claim 1, wherein said implant body has a total heightin an anterior posterior direction within a range of 10 mm to 40 mm anda width in a lateral direction within a range of 8 mm to 30 mm, when inan expanded configuration.
 13. The implant of claim 1, wherein aposterior side of the implant body is open.
 14. The implant of claim 1,wherein said cranial anterior apex is cranial to each said respectivecranial connection end.
 15. The implant of claim 14, wherein an angleformed by a cranial interconnecting member plane including said cranialanterior apex and each said respective cranial connection end forms anangle of between 10 to 50 degrees with said longitudinal axis in saidmedian plane.
 16. The implant of claim 1, wherein said caudal anteriorapex is cranial to each said respective caudal connection end.
 17. Theimplant of claim 16, wherein an angle formed by a caudal interconnectingmember plane including said caudal anterior apex and each saidrespective caudal connection end forms an angle of between 10 to 50degrees with said longitudinal axis in said median plane.
 18. Theimplant of claim 1, further comprising at least one intermediateinterconnecting member connecting a respective intermediate connectionend on each of said pair of posterolateral retractors to an intermediateanterior apex located on said median plane between said caudal anteriorapex and said cranial anterior apex and wherein each said respectiveintermediate connection end is located on a retractor of said pair ofposterolateral retractors between said respective caudal interconnectingmember extends laterally and posteriorly from said caudal anterior apexto each said respective intermediate connection end wherein each saidrespective intermediate connection end is located between one saidrespective cranial connection end and one said respective caudalconnection.
 19. The implant of claim 18, wherein said intermediateanterior apex is cranial to each respective intermediate connectionends.
 20. The implant of claim 16, wherein an angle formed by a caudalinterconnecting member plane including said caudal anterior apex andeach said respective caudal connection end forms an angle of between 10to 50 degrees with said longitudinal axis in said median plane.